Comments From the Department of Health and Human Services sidering, we cannot comment on whether they might bridge what we believe to be gaps in the Department's overall approach to developing quality assessment and assurance methods. The evidence to date, particularly the difficulties that arose with respect to the release of funds for the analysis of patient outcomes authorized by the Omnibus Budget Reconciliation Act of 1986 (see chapter 7), indicates that the coordination of research activities has been problematic. 2. The screening and profiling already performed by intermediaries and carriers to identify potentially inappropriate utilization suggest such tools may also have utility for identifying possible quality of care problems. For example, screens could identify cases of hospital-acquired infections. Quality screens might be most efficiently used by carriers and intermediaries at the point of bill processing to identify potentially substandard quality cases, even if PROS were given major responsibility for making final decisions about quality issues. We believe HCFA should explore the possibilities for improving the overall effectiveness of its medical review systems by testing the feasibility of using screens to target cases of substandard quality. Both the time and cost of developing such a study could be held within acceptable levels if the collection of clinical data were coordinated with PROS' ongoing review activities. 3. We are pleased that HCFA will consider taking actions to ensure that intermediaries and carriers report possible quality of care problems to PROS. Our wording of the recommendation has been changed to acknowledge that home health care is not denied because a patient requires a higher level of care. There are, however, instances where the interpretation of home health coverage guidelines may lead to denial of payment to patients with extensive care needs. As we understand the regulations, patients requiring more than intermittent care do not, in general, qualify for the Medicare benefit, although there are exceptions. Thus, a patient who could not be placed in an appropriate nursing home setting, or refused to be placed in a nursing home, could be denied Medicare home health care even though he or she had extensive posthospital care needs. The intent of the recommendation is to ensure that if, in the course of reviewing claims, an intermediary or carrier identifies any case where a premature or inappropriate discharge is suspected, even though the patient may not meet Medicare coverage guidelines for the service under review-as well as any other suspected quality of care problem—the PRO be notified. We have changed the wording of the recommendation to make this point clearer. Comments From the Department of Health and Human Services 4. HCFA's initiation of studies to analyze the effectiveness of PRO quality review methods is commendable. However, we do not know the details of the planned evaluation. Thus, we remain concerned about the importance of examining whether review methods can lead to actual changes in the incidence of quality problems over time, as well as their relative effectiveness in identifying cases with possible quality problems. 5. We acknowledge HCFA's need to consider the implications of legislative changes for claims processing and medical review activities. However, the expanded PRO review activities required by Public Law 99-509 should not preclude the screening or profiling of billing data by claims processors to detect possible quality of care problems in order to more effectively organize medical review activities. We believe that studying the possible realignment of review responsibilities among carriers, intermediaries, and PROS would be particularly important in view of HCFA's information system redesign. 6. HCFA supports that part of our recommendation for developing comparative information on the effectiveness of quality review methods used by the PROS in reviewing the quality of care in Medicare HMOs and CMPS. For an initial effort, the evaluation approach suggested by HCFAthat is, reporting information on the "incidence and distribution of problems" found in an HMO or CMP that could be "compared across HMOs and CMPS," along with "information on the scope of the internal quality assurance programs"-would begin to meet the intent of the recommendation. However, more extensive information must be collected to evaluate quality of care in HMOS and CMPS over the longer term. Without valid and comparable information on the use of services and health care outcomes across plans, it will be extremely difficult to determine whether the process of care within HMOs and CMPS is appropriate. Because PRO review of HMOS and CMPS is just beginning, HCFA has an opportunity to anticipate data needs and plan evaluations that can provide the information needed by the Medicare program, as well as by beneficiaries, on the quality of prepaid care. We believe that with appropriate sampling plans and data collection instruments, HHS could produce valid information for a reasonable cost. In our briefing report, Medicare: Preliminary Strategies for Assessing Quality of Care (GAO/PEMD-87-15BR), we noted that HCFA's objective of developing better information about the quality of care provided to Medicare beneficiaries is in potential conflict with its objective of moving toward systems of prepaid health care that provide less information about patients and their care than is currently available Comments From the Department of Health and Human Services for the fee-for-service population. This recommendation is intended to ensure that potentially serious problems of program accountability do not materialize. We agree that information on quality of care in prepaid settings should be compared to information regarding quality in fee-for-service settings. The need for a balanced view across both delivery systems is one of the underlying reasons for our discussion in chapter 6 of the need for comprehensive longitudinal information on the use, cost, and quality of care provided to all Medicare beneficiaries. We did not present a recommendation on this issue because we believe that such an ambitious undertaking should be planned as part of the comprehensive research and development activity discussed in chapter 7. However, we are pleased that HCFA agrees that this is an important issue. 7. It is encouraging that HCFA has reconsidered its earlier opposition to requiring diagnostic data on part B physician claims (see GAO/ PEMD-87-15BR, p.48) and is willing to test the gathering of such data for assigned claims. Our survey of carriers shows that the collection and use of these data are, at least for some carriers, both feasible and cost-effective. However, we would also urge HCFA to consider testing whether carriers-perhaps drawing upon their corporate experience in handling diagnostic information on commercial health insurance claims—can devise effective systems for obtaining reliable information on unassigned claims. 8. As HCFA notes, intermediaries and carriers currently keep track of data errors that might affect correct billing and return bills for correction when thresholds are exceeded. For example, intermediaries notify hospitals when they enter nonspecific diagnostic codes needed for DRG assignment in more than 10 percent of cases. We believe that similar standards of accuracy should be established for items that might affect quality of care determinations such as discharge destination and type and source of admission, as well as detailed diagnosis and procedure data beyond that needed for reimbursement decisions. One way to begin developing such standards is to keep track of errors uncovered in the course of case review and to allow claims processors the opportunity to work with providers to improve data quality. Over time, this would give physicians and other providers specific incentives to include correct information in billing data fields important for monitoring quality of care. Other issues related to improving data accuracy will be presented in our future report on Medicare patient outcome analyses. Comments From the Department of Health and Human Services With respect to HCFA's ongoing and planned efforts to improve the quality of data, it should be noted that researchers have found that Social Security Administration death records may also include errors (possibly because the precise date of death within a given month may not affect Social Security benefit calculations). Further, assessing the accuracy of discharge destination data requires confirmation of all posthospital care placements, not just those covered by Medicare. The Medicare automated data retrieval system data will only provide information on Medicare-covered home health or nursing home care, and not placement in private-pay or Medicaid posthospital care. 9. Our recommendation does not suggest that SuperPRO reviews would constitute a "total measure of PRO effectiveness" or that the SuperPRO should be the entity responsible for national assessments of quality of care. Nevertheless, much effort and expense is required to generate SuperPRO data, which are currently not generalizable and therefore relatively useless as an overall effectiveness indicator. The simple addition of a single data element to identify case selection criteria could make SuperPRO data of great interest and utility to policy makers, program administrators, and researchers. We do not understand why SuperPRO reviews, which replicate PRO quality of care and utilization reviews, would result in "grossly misleading" information if performed on appropriate samples. 10. HHS' plan to implement our recommendation regarding the development of a national data system tracking nursing home residents' health care status, needs, and outcomes is an important advance. However, HHS has not indicated plans for creating a similar system for home health care patient data. HCFA is required to collect these data for the facility survey and certification process for home health care providers under the provisions of the 1987 Omnibus Budget Reconciliation Act (Public Law 100-203). 11. The intent of the matter for consideration is to note the need for a clear delineation of responsibility for quality assurance research and development activities. We suggest that this charge be vested in a new federal entity or entities with expanded responsibilities, but we did not preclude existing HHS organizations as potential sites for such activities. Indeed, our discussion of potential sites includes several HHS offices. The matter for consideration has been clarified by the addition of the word "existing" in the phrase "new federal entity or existing entities." The key functions of any such entity-developing basic knowledge about Comments From the Department of Health and Human Services good medical practice and ways to incorporate this knowledge into quality assessment systems—are not currently the clear responsibility of any HHS agency or office. Thus, we do not agree with HCFA's assertion that this would lead to duplication of effort. Designation of responsibility is essential if the function is to be properly fulfilled. Developing methods for integrating the best standards of medical practice into Medicare quality review is an ancillary activity that could be conducted in or outside of HCFA. HCFA notes the potential for communications problems and we agree; careful coordination and routine exchange of information would be essential. 12. Our discussion of the PRISM system (p. 80) addresses HCFA's planned improvements. 13. The wording has been revised. 14. The wording has been clarified. 15. We have added a footnote indicating that hospital outpatient services will be included in PRO reviews. 16. The phrasing suggested by HCFA has been added. 17. The additional information provided by HCFA is included as a footnote on p. 20. 18. The discussion has been revised. 19. The more complete wording supplied by HCFA has been incorporated into the footnote. 20. The fiscal year 1988 figure supplied by HCFA has been inserted. The term "automatic" was intended to indicate that all cases described by the screen language would be denied payment. The wording has been clarified. 21. We acknowledge, on p. 27, that tighter parameters may be appropriate for some services in some areas. The possibility remains, however, that tighter parameters could mean that services flagged for review in one locality might not be in another. This could, in turn, lead some physicians or suppliers to be more cautious about billing for services and could possibly lead to inconsistent decisions about patient care across |